# P900052: Port-a-Cath (R) Epidural Implantable Access System

- Pathway: PMA
- Applicant: Smiths Medical Asd, Inc.
- Decided: Apr 22, 1991 after 277 days
- Product code: LNY (Catheter, Percutaneous, Long Term, Intraspinal)
- Device class: 3
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. PMA decisions do not claim a predicate device.

## Recalls of this device
- Mar 29, 2004 · Not classified · Z-0856-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri
- Mar 29, 2004 · Not classified · Z-0857-04: Some of the outer product pouches have voids in the seals and do not assure that the outer surfaces of the inner tray containing the port, catheter and procedural components remain sterile after steri

Source page: https://510kreport.com/device/P900052
Methodology: https://510kreport.com/methodology